Unusually Long Survival from Diagnosis (More Than Three Years to More Than 29 Years) in 27 Glioblastoma Patients Treated with Antineoplastons in Phase II Studies

Glioblastoma (GBM), the most common malignant primary brain tumor in adults, has a poor prognosis, with a median survival of 12-15 months. The morbidity of standard therapy can be devastating in long-term survivors. Twenty-six patients with GBM and one with gliosarcoma (GS) were treated with Antineoplastons A10 and AS2-1 (ANP) in Phase II clinical studies at the Burzynski Clinic. The unusually long survival and lack of long-term negative sequelae in these patients are emphasized. Eligibility criteria for protocol ANP included a Karnofsky/Lansky (KPS/LPS) score of 60 or higher and a life expectancy of two months or more. IV ANP was given to all patients, while some also received oral ANP. Gradually increasing doses of IV ANP were administered via subclavian catheter and infusion pump until maximum tolerated doses of A10 and AS2-1 were achieved. Outcome criteria were tumor response, survival, and toxicity. The Kaplan-Meier survival analysis for 574 GBM/GC patients receiving protocol ANP yielded a median survival of 0.966 years. Twenty-seven of these patients (4.7%) survived from more than 3 years to more than 29 years. Seven of these 27 patients survived more than 12 years, a definition of cure. Age at admission to BC ranged from 6.5 to 68.0 years, with a median age of 38.4 years. KPS/ LPS ranged from 40 to 100 with a median of 50. Patients with a KPS/LPS score of less than 60 received treatment as Special Exceptions. One patient experienced a serious adverse event possibly related to treatment and recovered fully. ANP shows promise in the treatment of GBM/GC.